Tissue repair

ABSTRACT

An apparatus includes a flexible fixation member having a body with a longitudinal extent and a width, the body defining a plurality of openings through the body, each of the plurality of openings formed substantially cross wise through the width of the body, and a suture having two terminal ends, the suture being interwoven through each of the plurality of openings in the body of the fixation member such that multiple portions of the fixation member are slidably coupled to the suture and configurable to form a cluster within a surgical site.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application is a continuation of U.S. patent application Ser. No.14/304,269, filed Jun. 13, 2014, now allowed, which is a divisional ofU.S. patent application Ser. No. 13/016,389, filed on Jan. 28, 2011, nowU.S. Pat. No. 8,795,334, issued Aug. 5, 2014. The entire contents of theprior applications are hereby incorporated herein by reference.

TECHNICAL FIELD

This disclosure relates to apparatus and methods for repairing tissue,and more particularly, to apparatus and methods for coupling soft tissueto bone.

BACKGROUND

Arthroscopic procedures using sutures and suture anchors have been usedin tissue repair to, for example, secure soft tissue to bone. Sutureanchors, such as metallic or other absorbable or non-absorbable polymermaterials, tend to displace a certain volume of bone to provide adequatefixation strength. The larger a necessary repair may require multipleanchors to properly reattach torn soft tissue to bone. The size of manyof these anchors can limit the number and location of fixation points aswell as affect the anatomic nature of some tissue repairs. Small anchorstypically do not provide sufficient holding strength to be effective insome tissue repair procedures or certain bone areas

SUMMARY

In one general aspect, an apparatus comprises a flexible fixation membercomprising a body with a longitudinal extent and a width, the bodydefining a plurality of openings through the body, each of the pluralityof openings formed substantially cross wise through the width of thebody, and a suture comprising two terminal ends, the suture beinginterwoven through each of the plurality of openings in the body of thefixation member such that multiple portions of the fixation member areslidably coupled to the suture and configurable to form a cluster withina surgical site.

Implementations may include one or more of the following features. Forexample, the flexible fixation member comprises one of a suture, tape,braid, or mesh. The flexible fixation member is non-tubular. Theflexible fixation member and the suture comprise a size 2 suture. Theapparatus further comprises a delivery device comprising a cannulaconfigured to receive the flexible fixation member therein. The deliverydevice further comprises an elongated member configured to slide withinthe cannula from a retracted position to an advanced position andconfigured to eject the flexible fixation member from the cannula whenthe elongated member is in the advanced position. The portions of thefixation member are configured to slide relative to the suture to form acluster comprising a group of folds within a surgical site. The sutureis interwoven through the plurality of openings in the fixation memberto form two substantially parallel tail sections of suture. The fixationmember comprises at least one curved portion that comprises, in seriesalong the curved portion, a first opening receiving a portion of one ofthe two parallel tail sections, a second and third opening receivingportions of the other of the two parallel tail sections, and a fourthopening receiving another portion of the one of the two parallel tailsections. The fixation member and the suture are formed from a materialthat is absorbable within a body of a patient. The fixation membercomprises a biologic growth material. In addition, the apparatus furthercomprises a second suture having two terminal ends, the second suturebeing interwoven through each of the plurality of openings in the bodyof the fixation member such that portions of the fixation member areslidably coupled to the suture.

In another general aspect, an assembly comprises a non-tubular tissueanchor formed from one of a suture, mesh, braid, or tape, the tissueanchor comprising a body with a longitudinal extent and a width, thebody defining a plurality of openings along the longitudinal extent ofthe body and through the width of the body, a suture interwoven througheach of the plurality of openings in the body of the tissue anchor suchthat portions of the tissue anchor are slidable relative to the sutureand configurable to form a cluster within a surgical site, and adelivery device comprising a cannula configured to receive the flexiblefixation member therein.

Implementations may include one or more of the following features. Forexample, the delivery device further comprises an elongated memberconfigured to slide within the cannula from a retracted position to anadvanced position and configured to eject the flexible fixation memberfrom the cannula when the elongated member is in the advanced position.The tissue anchor and the suture comprise a size 2 suture. The portionsof the tissue anchor are configured to slide relative to the suture toform a cluster comprising a group of folds within a surgical site. Thesuture is interwoven through each of the plurality of openings in thetissue anchor to form two substantially parallel tail sections ofsuture. The tissue anchor and the suture are formed from a material thatis absorbable within a body of a patient. The tissue anchor comprises abiologic growth material.

In another general aspect, an apparatus comprises a tissue anchorcomprising a plurality of connected knots, and a suture comprising twoterminal ends, the suture passing through one or more of the pluralityof connected knots such that the tissue anchor is slidably coupled tothe suture.

Implementations may include one or more of the following features. Forexample, the plurality of connected knots comprise, in sequence, a firstsquare knot, two free alternating post half hitch knots, a second squareknot, two free alternating post half hitch knots, and a third squareknot. The suture passes through each of the first, second, and thirdsquare knots. The apparatus further comprises a second suture having twoterminal ends, the second suture passing through one or more of theplurality of connected knots such that the tissue anchor is slidablycoupled to the second suture. The tissue anchor and the suture areformed from a material that is absorbable within a body of a patient.The tissue anchor comprises a biologic growth material. The apparatusfurther comprises a delivery device comprising a cannula configured toreceive the tissue anchor therein. The delivery device further comprisesan elongated member configured to slide within the cannula from aretracted position to an advanced position and configured to eject thetissue anchor from the cannula when the elongated member is in theadvanced position.

In another general aspect, a wound closure assembly comprises a tissueanchor comprising a plurality of connected knots, and a suturecomprising two terminal ends, the suture passing through one or more ofthe plurality of connected knots such that the tissue anchor is slidablycoupled to the suture, and a delivery device comprising a cannulaconfigured to receive the tissue anchor therein.

Implementations may include one or more of the following features. Forexample, the delivery device further comprises an elongated memberconfigured to slide within the cannula from a retracted position to anadvanced position and configured to eject the tissue anchor from thecannula when the elongated member is in the advanced position.

In another general aspect, a method of closing a tissue wound comprisesdelivering a wound closure device to a surgical site, the wound closuredevice comprising a flexible fixation member having a body with alongitudinal extent and a width, the body defining a plurality ofopenings through the body, each of the plurality of openings formedsubstantially cross wise through the width of the body, and a suturehaving two terminal ends, the suture being interwoven through each ofthe plurality of openings in the body of the fixation member such thatmultiple portions of the fixation member are slidably coupled to thesuture and configurable to form a cluster within a surgical site,removing the flexible fixation member from the wound closure device atthe surgical site, and pulling on the terminal ends of the suture toform a cluster of the multiple portions of the fixation member at thesurgical site.

Implementations may include one or more of the following features. Forexample, the method further comprises drilling a hole into the tissue.The removing step comprises ejecting the flexible fixation member fromthe device into the hole. The hole passes completely through the tissueand the delivering step comprises delivering the device through the holeand the removing step comprises placing the flexible fixation member onan opposite side of the hole. The method further comprises maintainingthe wound closure device in position at the surgical site as theterminal ends of the suture are pulled to form the cluster of themultiple portions of the fixation member at the surgical site.

In another general aspect, a method of closing a tissue wound, comprisesdelivering a wound closure device to a surgical site, the wound closuredevice comprising a tissue anchor having a plurality of connected knots,and a suture having two terminal ends, the suture passing through one ormore of the plurality of connected knots such that the tissue anchor isslidably coupled to the suture, removing the tissue anchor from thewound closure device at the surgical site, and pulling on the terminalends of the suture to form a cluster of the plurality of connected knotsat the surgical site.

Implementations may include one or more of the following features. Forexample, the method further comprises drilling a hole into the tissue.The removing step comprises ejecting the tissue anchor from the deviceinto the hole. The hole passes completely through the tissue and thedelivering step comprises delivering the device through the hole and theremoving step comprises placing the tissue anchor on an opposite side ofthe hole. The method further comprises maintaining the wound closuredevice in position at the surgical site as the terminal ends of thesuture are pulled to form the cluster of the plurality of connectedknots at the surgical site.

The details of one or more implementations of the disclosure are setforth in the accompanying drawings and the description below. Otherfeatures and advantages will be apparent from the description anddrawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates an implementation of a tissue repair apparatus.

FIG. 1B illustrates another implementation of a tissue repair apparatus.

FIG. 1C illustrates an implementation of a tissue repair apparatus aftersliding of curved portions of a fixation member with respect to a sutureto form a cluster or bunch including a number of folds.

FIG. 2 illustrates the tissue repair apparatus of FIG. 1A including anadditional suture interwoven through the construct.

FIG. 3 illustrates an alternative implementation of weaving the suturethrough the fixation member of FIG. 1A.

FIG. 4 illustrates another implementation of a tissue repair apparatus.

FIG. 5 illustrates the tissue repair apparatus of FIG. 4 including anadditional suture interwoven through the construct.

FIGS. 6A-6G illustrate implementations of delivery devices used fordelivery and placement of the tissue repair apparatuses of FIGS. 1A-5 ata surgical site.

DETAILED DESCRIPTION

Referring to FIG. 1A, a tissue repair apparatus 100 includes a fixationmember or anchor 10 and a flexible member or suture 20 interwoventhrough the fixation member 10. The fixation member 10 is formed of amalleable or flexible braided body 12 having a longitudinal extentextending between a first end 12 a and a second end 12 b and a width W.The body 12 defines a plurality of openings 14 formed crosswise through,or substantially along, the width W of the body 12. The suture 20includes two terminal ends, 20 a and 20 b. One of the terminal ends 20a, 20 b is passed through each of the openings 14 in the body 12 formingmultiple curved portions 30 of the fixation member 10 and twosubstantially parallel sections 22, 24 of the suture 20. As shown inFIG. 1A, the curved portions 30 pass from one section 22, 24 to theother of the sections 22, 24 along the length of the fixation member 10to form substantially S-shaped curved portions 30. The curved portions30 may slide with respect to the suture 20 to form a cluster or bunch 30including a number of folds as shown in FIG. 1C. The cluster 30, inconjunction with the terminal ends 20 a, 20 b, may be used to securetissue within a surgical site as will be described in more detail below.

In the implementation shown in FIG. 1A, the fixation member 10 and thesuture 20 are made from size 2 non-tubular braided sutures. However, thefixation member 10 may be a tape, mesh, tube, or other type of malleableor flexible structure, and the suture 20 may be made from a suture ofdifferent size depending upon the surgical procedure or application. Forexample, in another exemplary implementation, the fixation member 10and/or the suture 20 are made from a flattened tubular suture. Inaddition, while the fixation member 10 of FIG. 1A includes at least fourcurved portions 30, other configurations are possible, such as theimplementation shown in FIG. 1B, where the fixation member 10 has asmaller length dimension and therefore includes three curved portions 30when the suture 20 is interwoven therethrough. In yet anotherimplementation, the fixation member 10 can include two curved portions30 and be formed substantially in a S-shaped configuration. Varying thelength and width dimensions of the fixation member 10, and/or varyingthe size of the suture 20, and/or the number of openings through thefixation member 10 through which the suture 20 passes, may affect thesize of the cluster 30 formed by the fixation member 10 within thesurgical site. These varying configurations may provide the user withflexibility to meet the needs for a number of various surgicalprocedures.

Referring to FIG. 2, the tissue repair apparatus 100 of FIG. 1A may alsoinclude an additional flexible member or suture 40 having two terminalends 40 a, 40 b. One of the two ends 40 a, 40 b may be interwoven aroundor through the fixation member 20 forming a construct yielding four freeends 20 a, 20 b, 40 a, and 40 b. An apparatus with four free ends mayhave advantages over two free ends in certain implementations. Forexample, in some applications, such as rotator cuff repair, it is oftennecessary to tie down the tissue to the bone at two locations in orderto secure the tissue to the bone. In these applications, providing fourfree ends with only one fixation member within the bone reduces thenumber of fixation members needed, which may lower procedure time andcost. Reducing the number of fixation members may also reduce the riskof stress concentrations due to multiple drilled holes causing a risk offracture at the repair site post-operatively.

Referring to FIG. 3, an alternative implementation of weaving the suture20 through the fixation member 10 of FIG. 1A is illustrated. One of theterminal ends 20 a, 20 b is passed through each of the openings 14 inthe body 12 forming multiple curved portions 30 of the fixation member10 and two substantially parallel sections 22, 24 of the suture 20.Unlike the curved portions 30 formed by the weaving pattern illustratedin FIG. 1A, the curved portions 30 of FIG. 3 do not pass from one tailsection 22, 24 to the other of the tail sections 22, 24 along the lengthof the fixation member 10 to form substantially S-shaped curved portions30. Instead, in the implementation shown in FIG. 3, curved portions 30form substantially S-shaped curved portions 30 along the length of theportion of the suture 10 that is interwoven through the fixation member10. This weaving pattern may allow for a smaller diameter hole to bedrilled into bone for receiving the fixation member 10, which may aid inthe reduction of stress concentrations and fracture. In addition, theweaving pattern may permit access to surgical sites that are too smallor confined for existing tissue anchor assemblies.

Referring to FIG. 4, in another implementation, an apparatus for tissuerepair 200 includes a fixation member or anchor 210 and the flexiblemember or suture 20 interwoven through the fixation member 210. Thefixation member 210 may be formed as a sequence of connected knots 215.In the particular implementation shown in FIG. 4, the sequence of knots215 includes a square knot 220, two free alternating post half hitchknots 222, 224, a square knot 226, two free alternating post half hitchknots 228, 230, and a square knot 232. The suture 20 may pass througheach of the square knots 220, 226, and 232, or any combination of one ormore openings formed by the connected knots 215 that permits thefixation member 210 to slide relative to the suture 20 so that thefixation member 210 may form a cluster or bunch within the surgical siteand cooperate with the suture 20 to secure tissue within the surgicalsite as will be described in more detail below. The fixation member 210and the suture 20 are made from size 2 braided sutures, however, othersuture sizes may be employed or tailored for, for example, drill sizeand strength requirements.

Referring to FIG. 5, the tissue repair apparatus 200 of FIG. 4 may alsoinclude an additional flexible member or suture 40 having two terminalends 40 a, 40 b. One of the two ends 40 a, 40 b may be interwoven aroundor through the fixation member 210, and more particularly, through oneor more openings formed by the sequence of knots 215, forming aconstruct yielding four free ends 20 a, 20 b, 40 a, and 40 b. Asdiscussed above, an apparatus with four free ends may have advantagesover two free ends in various implementations.

FIGS. 6A-6E represent a tool or delivery device 300 used to deliver anyone of the fixation members 10, 210 described with respect to FIGS. 1A,1B, and 2-3 to a surgical site for repairing, as an example, soft tissue314. Referring to FIG. 6A, the delivery device 300 includes an insertertube or cannula 302. One of the fixation members 10, 210 is loaded intothe tube or cannula 302 as shown by the arrow in FIG. 6A such that thefree ends 20 a, 20 b of the suture 20 extend through a proximal end 302a of the inserter tube 302 such that the free ends 20 a, 20 b may bemanipulated by a physician. As shown in FIG. 6B, a drill guide 304 isplaced within the surgical site 400 and a drill (not shown) is placedwithin the drill guide 304 and is used to drill a hole 306 of sufficientdepth through the cortical layer 310 and into the cancellous bone tissue312. Alternatively, the drill may be used to drill completely throughthe cancellous bone tissue 312 in the case of transosseous repairapplications. Once the hole 306 is formed in the surgical site 400, theinserter tube 302 containing the loaded fixation member 10, 210 isinserted through the drill guide 304 and into a desired position at thesurgical site 400, for example, the inserter tube 302 is tapped into thecortical layer 310.

Referring to FIG. 6C, the inserter tube 302 may then be moved or tappedfurther into the hole 306 with the fixation member 10, 210 remaining inposition within the inserter tube 302. Once the tube 302 is in thedesired position within the hole 306, the user may then draw theinserter tube 302 back leaving the fixation member 10, 210 within thehole 306 in the bone (FIG. 6D), or alternatively, on an opposite side ofthe bone in a transosseous application.

Referring to FIG. 6E, with the fixation member 10, 210 positioned withinthe hole 306 and a distal end 302 b of the inserter tube 302 positionedat the surgical site 400, for example, at or below the cortical layer310, the user may then pull on one or both of the free ends 20 a, 20 bof the suture 20. Pulling one or both of the free ends 20 a, 20 b(and/or the free ends 40 a, 40 b in those implementations employing twosutures, such as sutures 20, 40 shown in FIG. 2) causes the fixationmember 10, 210 to seat against the distal end 302 b of the inserter tube302. As the user continues to pull one or both of the free ends 20 a, 20b, the fixation member 10, 210 slides relative to the suture 20, andmore particularly, the curved portions 30 of the fixation member 10, orthe sequence of knots 215 of the fixation member 210, slide relative tothe suture 20 to come together to form a bunch or cluster 30 within thehole 306, for example, at or below the cortical layer 310. With thefixation member 10, 210 in the desired position, the user may thenremove the inserter tube 302 and drill guide 304 from the surgical site400 and tie the free ends 20 a, 20 b (and/or the free ends 40 a, 40 b)to secure the tissue 314 to the bone 312.

Maintaining the inserter tube 302 in place throughout insertion anddeployment of the fixation member 10, 210 into the surgical site 400 mayprovide the user with tactile feedback that the fixation member 10, 210is seated against the inserter tube 302. This may be advantageous overprocedures that rely instead on the cortical layer 310 to provide ahard-stop against deployment of the fixation member 10, 210 within thesurgical site 400. In those systems, the user feels a fixation memberseat or deploy once it contacts the cortical layer 310, which is ofvarious densities across patients. Therefore, the cortical layer 310 insome patients may feel like a hard stop, and in some patients may feellike a soft stop. Thus, there is an increased risk of pulling thefixation member out when trying to deploy or seat the fixation memberwhen relying on the cortical layer to provide a stop to fixation memberdeployment. In contrast, in the present implementation, the user isprovided with a tactile feedback through the inserter tube 302 that thefixation member 10, 210 has deployed and has formed the requisite bunchor cluster within the surgical site 400. This helps reduce the risk ofpulling the fixation member 10, 210 out when deploying and seating thefixation member 10, 210.

A number of implementations of the invention have been described.Nevertheless, it will be understood that various modifications may bemade without departing from the spirit and scope of the invention. Forexample, the fixation members and the flexible members may include agrowth factor, such as, for example, an angiogenic factor. The fixationmembers and the flexible members may also be loaded with a bioactivematerial, a stimulant, or any substance that promotes healing of thetissue. In addition, while the openings formed in the body of thefixation member are described as being formed substantially crosswisethrough the body, they may be formed in other orientations depending onthe particular application. Moreover, the openings may be formed in thebody of the fixation member prior to passing the flexible member throughthe openings, or the opening may be formed by passing the flexiblemember through the body of the fixation member, such as, for example, bypassing a needle loaded with the flexible member through the body of thefixation member to form a desired number of openings in the fixationmember.

In addition, although the process has been described for applicationswhere the fixation member is secured within a hole drilled into bone,the fixation members may also be used in transosseous applications wherethe depth of the hole is not a constraint. In these applications, thefixation member may be passed entirely through the hole and secured onthe backside of the bone. In an alternative implementation (FIG. 6F),the inserter tube 302 may be maintained on top of the cortical layer 310throughout insertion of the fixation member 10, 210 into the hole 306.In such an implementation, the delivery device 300 includes a slidemember 320 disposed within the inserter tube 302 and coupled to thefixation member 10, 210. The user may move the slide member 320 forwardwithin the inserter tube 302 to deploy the fixation member 10, 210 fromthe inserter tube 302 and into the hole 306. In yet another alternativeimplementation (FIG. 6G), the delivery device 300 may include a tube 330placed through the drill guide 304. The tube 330 is tapped into thecortical layer 310 and then receives the inserter tube 302 therethrough.In addition, although the delivery device 300, including the insertertube 302, has been shown with a straight configuration, the deliverydevice 300, including the inserter tube 302, may have a curved shape orother suitable configuration depending on the particular surgicallocation and procedure to be performed.

Moreover, in addition to the particular knot sequence described withrespect to the fixation member 210 of FIG. 4, it should be understoodthat various knot sequences and sizes, and suture sizes, may be useddepending on the particular application. Accordingly, otherimplementations are within the scope of the following claims.

1. (canceled)
 2. An apparatus for insertion into a bone hole comprising:a flexible fixation member comprising a body formed by two legs and adistal, U-shaped bend joining the two legs, each of the legs terminatingin a proximal free end; and a suture received through each of the legsof the flexible fixation member, the suture formed by two legs and adistal, U-shaped bend joining the two legs, each of the suture legshaving a proximal end region, one of the proximal end regions extendingfrom an opening in one of the legs of the body and the other of theproximal end regions extending from an opening in the other of the legsof the body with each proximal end region terminally exiting from thefixation member at the respective opening, the U-shaped bend of thesuture being distal to the U-shaped bend of the body; wherein thefixation member having the U-shaped bend is slidably coupled to thesuture and configurable to form a cluster within a surgical site; andwherein the suture extends longitudinally down one leg of the fixationmember and longitudinally up the other leg of the fixation member in asingle direction without intersecting itself.
 3. The apparatus of claim2, wherein the fixation member comprises suture, tape, braid or mesh. 4.The apparatus of claim 2, wherein the suture only extends a single timethrough the openings.
 5. The apparatus of claim 2, wherein the clusteris defined by a group of folds.
 6. The apparatus of claim 2, wherein theopening in the one of the legs is spaced from a terminus of the proximalfree end of the one of the legs, and the opening in the other of thelegs is spaced from a terminus of the proximal free end of the other ofthe legs.
 7. The apparatus of claim 2, wherein the suture comprises asize 2 suture.
 8. The apparatus of claim 2, further comprising adelivery device comprising a cannula configured to receive the fixationmember therein.
 9. The apparatus of claim 2, wherein an entirety of thesuture, including each of the proximal end regions, is slidable withrespect to an entire longitudinal extent of the fixation member ineither direction.
 10. The apparatus of claim 2, wherein a width of thefixation member is uniform along an entire length of the fixationmember.